Executive Director, Quality Assurance & Compliance

WuXi Biologics; Cranbury Township (NJ); On-site; USD 160,000 - 260,000; Full time

Job summary

WuXi Biologics in Cranbury, NJ is seeking an Executive Director, Quality Assurance to lead the U.S. QA/QC organization, shaping strategy, ensuring GxP compliance, and driving continuous improvement across R&D, clinical, CMC, and manufacturing.

This senior role requires deep regulatory knowledge, cross-functional leadership, and a proven track record in inspection readiness and quality management systems for biopharmaceuticals. On-site presence is required; travel as needed.

Qualifications

• Bachelor's or higher in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, Biological Engineering, or related field; advanced degree preferred.
• 15+ years in pharma/biotech with at least 10 years in Quality leadership or Quality management.
• GMP-regulated biopharmaceutical/biologics or CDMO experience; antibody-drug conjugates desirable.
• Proven leadership of cross-functional QA in multi-site/international settings.
• Deep knowledge of global GxP regulations, regulatory inspections, and compliance frameworks.

Responsibilities

• Provide strategic and scientific leadership for the U.S. quality organization and align with global QA strategy.
• Lead QA and QC functions supporting R&D, Clinical, CMC, tech transfer, manufacturing, and commercial ops.
• Ensure risk-based Quality Management System, document control, CAPA, deviations, and training.
• Lead regulatory inspections and client audits, with proactive remediation and effectiveness monitoring.
• Oversee product disposition, batch records, and quality governance across sites.

Skills

Strategic leadership

Regulatory knowledge

Cross-functional leadership

Quality mindset

Communication skills

Education

Bachelor's degree or higher in Chemistry/Biology/related field

Advanced degree preferred

Job description

WuXi Biologics in Cranbury, NJ is seeking an Executive Director, Quality Assurance to lead the U.S. QA/QC organization, shaping strategy, ensuring GxP compliance, and driving continuous improvement across R&D, clinical, CMC, and manufacturing.

This senior role requires deep regulatory knowledge, cross-functional leadership, and a proven track record in inspection readiness and quality management systems for biopharmaceuticals. On-site presence is required; travel as needed.